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General Information

Zinbrtya is specifically indicated for the treatment of adult patients with relapsing forms of multiple sclerosis. Because of its safety profile, the use of Zinbryta should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

Zinbrtya is supplied as a solution for subcutaneous injection. The recommended dose is 150 milligrams injected subcutaneously once monthly. Patients should inject a missed dose as soon as possible but no more than two weeks late. After two weeks, skip the missed dose and take the next dose on schedule. Administer only one dose at a time. Please see drug label for specific administration instructions.

Clinical Results

FDA Approval

The FDA approval of Zinbryta was based on two randomized, double-blind, controlled studies (Study 1 and Study 2). Both studies evaluated 150 mg of subcutaneous Zinbryta taken once every four weeks in patients with relapsing multiple sclerosis (RMS).

Study 1: Active-Controlled Trial in RMS. Study 1 compared Zinbryta to 30 mcg weekly intramuscular doses of Avonex in 1,841 patients for 144 weeks. The primary outcome measure of Study 1 was the annualized relapse rate (ARR). Zinbryta had a statistically significant effect on the annualized relapse rate and on the number of new or newly enlarging T2 hyperintense lesions.

Study 2: This study compared Zinbryta to placebo in 412 patients who were treated for 52 weeks. The primary outcome measure of Study 2 was the annualized relapse rate (ARR) at Week 52. Zinbryta had a statistically significant effect on the annualized relapse rate, the proportion of patients relapse free, the number of new T1 Gd-enhancing lesions, and the number of new or newly enlarging T2 hyperintense lesions.

Side Effects

Adverse effects associated with the use of ZInbryta may include, but are not limited to, the following:

compared to Avonex:

nasopharyngitis

upper respiratory tract infection

rash

influenza

dermatitis

oropharyngeal pain

bronchitis

eczema

lymphadenopathy

compared to placebo:

upper respiratory tract infection

depression

rash

pharyngitis

increased alanine aminotransferase (ALT)

Zinbryta comes with a black box warning of the potential for hepatic injury including autoimmune hepatitis and other immune-mediated disorders.

Mechanism of Action

Zinbryta (daclizumab) is an interleukin-2 receptor blocking humanized monoclonal antibody. The precise mechanism by which daclizumab exerts therapeutic effects in multiple sclerosis is unknown but is presumed to involve modulation of IL-2 mediated activation of lymphocytes through binding to CD25, a subunit of the high-affinity IL-2 receptor.